As it turns out, my skepticism was warranted. Once again, we have proof that commerce and science do not mix, and that people suffer direct harm as Big Pharma lunges for the money:
Dr. Rokuro Hama runs the Japan Institute of Pharmacovigilance, an Osaka-based nonprofit group that monitors pharmaceutical product safety. In 2002, shortly after Tamiflu was introduced in Japan, he received a number of case reports of children who had begun behaving strangely within hours of taking it. A fourteen-year-old boy wandered out of his family’s ninth-floor apartment and jumped over an exterior railing to his death; a seventeen-year-old boy ran out of his house onto a nearby freeway, where he was killed by a speeding truck; a thirty-nine-year-old man and two three-year-old boys died suddenly in their sleep.
...Hama reanalyzed the Yokohama data and estimated that Tamiflu resulted in a fourfold increase in the frequency of hallucinations and other neuropsychiatric side effects in children with influenza. A journalist later alerted Hama to the fact that Chugai, the Roche subsidiary that markets Tamiflu in Japan, had provided funds for research to two of the scientists who worked on the Yokohama study. While there is no evidence of wrongdoing, such funding always raises the possibility of a conflict of interest.
...While Kaiser’s finding seemed powerful, Hayashi was concerned that the drug’s entire reputation seemed to rest on this one article and a small number of others. He contacted Tom Jefferson, a British influenza expert with the Cochrane Collaboration, a British government–funded network of epidemiologists that conducts independent reviews of medical research. The Cochrane group had published a favorable review of Tamiflu in 2006, based largely on the same articles that Hayashi had read.
When Jefferson and his colleagues read Hayashi’s letter, they too began to wonder whether their initial assessment had been correct. They noticed several ambiguities and errors in Kaiser’s article that they hadn’t recognized before. For example, the definition of “complications related to influenza” used by the doctors in the study was imprecise, which made it difficult to tell what the study was actually measuring; in addition, the high rate of influenza seen in the clinics where the trials were carried out also seemed odd. Normally, only about 15 percent of what seem like “flu” cases are actually found upon lab testing to be caused by the influenza virus—the others are caused by some other microbe. But in the clinics where the Tamiflu trials were conducted, up to 80 percent of flu-like illnesses were reported to have been caused by influenza itself, raising the possibility that the patients had been selected for some reason that wasn’t made clear in the article.
...In Kaiser’s case, one blunder was obvious: the authors had combined the results of several smaller studies to come to the conclusion that Tamiflu reduced complications and hospitalizations. Combining the studies in that way destroyed the “randomization” so the placebo and Tamiflu groups were no longer necessarily similar.
...When Jefferson became aware of the problems with Kaiser’s article and other papers on Tamiflu, he asked the authors for their original raw data so that he and his colleagues could redo the analysis themselves. But Kaiser and the others said that they couldn’t find the data, and suggested that he contact the company. After a delay of several months, Roche officials sent the Cochrane group a set of “research summaries” that essentially restated the results presented in the articles he was concerned about.
...Meanwhile, the Cochrane team, which had by then grown to seven members, spent much of 2010 sifting through the heap of documents—some 3,200 pages in all—that Roche made available to them. They also assembled a dossier of information on Tamiflu from various other sources, including the FDA and other national drug regulators. In doing so, they noticed yet more discrepancies between the articles that had appeared in scientific journals and Roche’s internal documents, many concerning the drug’s safety. According to published articles, no potentially drug-related serious side effects—or “serious adverse events” as they are called—were reported in the papers describing two Roche-sponsored clinical trials in which 908 people took Tamiflu; but according to Roche’s unpublished documents, three “serious adverse events” that were possibly related to Tamiflu occurred in these trials.
In 2008, an article in the journal Drug Safety, signed by a group of Roche authors, claimed that rats and mice, both given a very high dose of Tamiflu, showed no ill effect. But according to documents submitted to the Japanese Ministry of Health, Labor, and Welfare by Chugai, the Japanese Roche subsidiary, the exact same dose of Tamiflu killed more than half of the animals. As they died, the rats exhibited many of the same central nervous system symptoms that Hama had described in his case series on the Japanese children.
The Cochrane group found, moreover, that cases of hallucination and weird accidents have been fairly commonly reported in Roche’s post-marketing surveillance of Tamiflu. An article in The International Journal of Clinical Practice claimed that these symptoms were just as common in influenza patients who did not take Tamiflu. However, the data on which that observation is based have not been made public.
...During the ten years leading up to the pandemic declaration of 2009, scientists associated with the companies that were to profit from the WHO’s “pandemic preparedness” programs, including Roche and GlaxoSmithKline, were involved at virtually every stage of the development of those programs. The companies funded the documents giving guidance on preparing for the influenza pandemic, in which the WHO recommended the stockpiling of Tamiflu and Relenza. Consultants drafted parts of these documents and joined WHO officials in fund-raising for the Tamiflu stockpile. Industry-supported scientists were also on the committee that issued the “pandemic emergency declaration.” That announcement caused developing countries to request assistance from the WHO’s Tamiflu stockpile fund, and these requests contributed to a tripling of the drug’s sales in 2009. By declaring a pandemic and linking the response to Tamiflu stockpiling, the WHO could not have done a better job of promoting Roche’s interests. Until Roche shares more information on Tamiflu with independent researchers, we won’t know whether the agency did so at the expense of the rest of us.
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